Replimune Reports Fiscal Second Quarter 2024 Financial Results and Provides Corporate Update
November 07 2023 - 8:00AM
Replimune Group, Inc. (NASDAQ: REPL), a clinical stage
biotechnology company pioneering the development of a novel
portfolio of oncolytic immunotherapies, today announced financial
results for the fiscal second quarter ended September 30, 2023 and
provided a business update.
“We look forward to presenting the topline data
from our registration-directed CERPASS clinical trial of RP1 in
combination with Libtayo in cutaneous squamous cell carcinoma
(CSCC) as well as sharing an initial snapshot from the full patient
population in the IGNYTE clinical trial cohort of RP1 combined with
Opdivo in anti-PD1 failed melanoma at an investor call in a few
weeks time,” said Philip Astley-Sparke, CEO of Replimune. “We are
also excited to present the design of a confirmatory study agreed
with the FDA to support a potential approval of RP1 in anti-PD1
failed melanoma via the accelerated approval pathway. For RP2 and
RP3, we are continuing to see anti-tumor activity in our Phase 1
program and look forward to providing a full update in early
2024.”
Program Highlights &
Milestones
RP1
- CERPASS clinical trial of RP1 combined with
Libtayo® (cemiplimab-rwlc) in CSCC
- The trigger for the primary analysis from the
registration-directed CERPASS clinical trial occurred in late June
and data collection activities are now complete. The independent
review process is expected to complete shortly, triggering a
defined process timeline to disclosure in early December.
- Assuming positive data demonstrating overall clinical benefit,
the Company plans to submit a Biologics License Application (BLA)
for RP1 in Q2 2024.
- RP1 combined with Opdivo®
(nivolumab) in anti-PD1 failed melanoma
- The Company will present initial snapshot data for all patients
on its conference call in early December by which point all
patients will have had at least 6 months follow up. The Company
also plans to provide a regulatory update including the design of
the intended confirmatory clinical trial to support a potential
approval under the accelerated pathway. Planning for the
confirmatory study is underway to ensure it has commenced ahead of
any BLA submission. The per protocol primary analysis will take
place 12 months post the last patient enrolled. Accordingly, the
Company plans to submit the BLA in Q3 2024.
- RP1 combined with Opdivo in anti-PD1 failed
non-melanoma skin cancers (NMSC)
- Recruitment remains ongoing into the cohort of patients with
anti-PD1 failed NMSC, including CSCC. The Company plans to provide
a data update of the first 30 patients with at least 6 months
follow up on its conference call in early December.
- RP1 in solid organ transplant recipients with skin
cancers
- Presented initial data from the ARTACUS clinical trial of RP1
monotherapy in solid organ transplant recipients with skin cancers
at the Society for Immunotherapy of Cancer’s (SITC) 38th Annual
Meeting in November 2023. The data included 23 evaluable patients
with CSCC (n=20) and Merkel cell carcinoma (n=3).
- The data demonstrated an overall response rate (ORR) of 34.5%
and a confirmed complete response (CR) rate of 21%.
- RP1 monotherapy was well tolerated, and the safety profile was
similar to non-immunocompromised patients with advanced skin
cancers (i.e. from the IGNYTE study). No immune-mediated adverse
events or evidence of allograft rejection were observed.
RP2 and RP3
- RP2 and RP3 Phase 1 program
- Accrual in the Phase 1 program is now substantially complete.
Any additional Phase 2 development programs not already announced
which are driven by data from the full Phase 1 data and other
opportunistic considerations are expected to be announced in early
2024.
- The Company will present updated data from a cohort of
metastatic uveal melanoma patients enrolled in the open-label,
multicenter Phase 1 study of RP2 as a single agent and in
combination with nivolumab during a Plenary Session at the 20th
Annual International Society for Melanoma Research Congress on
November 8, 2023.
- RP2 and RP3 Phase 2 program
- RP2 and RP3 in combination with atezolizumab and bevacizumab in
third-line colorectal cancer (CRC)
- Two signal finding cohorts of 30 patients each are being
enrolled in collaboration with Roche. Patients in the first cohort
will be treated with atezolizumab combined with bevacizumab and RP2
and the second cohort with atezolizumab and bevacizumab and RP3.
This clinical trial is ongoing.
- RP2 and RP3 in combination with atezolizumab and bevacizumab in
second-line (2L) hepatocellular carcinoma (HCC)
- Two signal finding cohorts of 15 patients each will be enrolled
in collaboration with Roche. The first cohort will enroll 2L
patients treated with standard of care atezolizumab combined with
bevacizumab and RP3, and the second cohort will enroll 2L patients
treated with atezolizumab combined with bevacizumab and RP2. This
clinical trial has recently initiated.
- RP3 in combination with standard of care therapy in squamous
cell carcinoma of the head and neck (SCCHN)
- Initiation has been delayed due to the global shortage of
cisplatin and carboplatin.
Corporate Update
- Announced the appointment of Emily Hill as Chief Financial
Officer (CFO). Ms. Hill was most recently CFO of the commercial
stage biotech company PTC Therapeutics and has more than 15 years
of experience in the biotechnology and life sciences industry
having held senior financial management and investor relations
roles at several leading public biotechnology and pharmaceutical
companies.
- Due to the timing of expected data, the company will commence a
quiet period on November 13, 2023 that will remain in effect until
the planned conference call in early December.
Financial Highlights
- Cash Position: As of September 30,
2023, cash, cash equivalents and short-term investments
were $496.8 million, as compared to $583.4
million as of March 31, 2023. The decrease was primarily
related to cash utilized in operating activities in advancing the
Company’s expended clinical development plans.Based on the current
operating plan, the Company believes that existing cash, cash
equivalents and short-term investments, as of September 30, 2023,
will enable the Company to fund operations into the second half of
calendar year 2025.
- R&D Expenses: Research and
development expenses were $49.1 million for the second
quarter ended September 30, 2023, as compared to $28.8
million for the second quarter ended September 30, 2022.
This increase was primarily due to increased clinical and
manufacturing expenses driven by the Company’s lead programs and
increased personnel expenses. Research and development expenses
included $4.4 million in stock-based compensation
expenses for the second quarter ended September 30, 2023.
- S,G&A Expenses: Selling, general and
administrative expenses were $14.7 million for the second
quarter ended September 30, 2023, as compared to $12.7
million for the second quarter ended September 30, 2022.
The increase was primarily driven by personnel related costs,
including sales and marketing personnel associated with pre-launch
planning and build of the Company’s commercial infrastructure.
Selling, general and administrative expenses included $4.7
million in stock-based compensation expenses for the second
quarter ended September 30, 2023.
- Net Loss: Net loss was $60.0
million for the second quarter ended September 30, 2023,
as compared to a net loss of $43.1 million for the second
quarter ended September 30, 2022.
About CERPASS CERPASS is
Replimune’s registration-directed randomized, global Phase 2
clinical trial to compare the effects of Libtayo® (cemiplimab-rwlc)
alone versus a combination of Libtayo and Replimune’s
investigational oncolytic immunotherapy RP1. The clinical trial
enrolled 211 patients with locally advanced or metastatic cutaneous
squamous cell carcinoma who are naïve to anti-PD-1 therapy. The
clinical trial will evaluate complete response rate and overall
response rate as its two independent primary efficacy endpoints as
assessed by independent review, as well as secondary endpoints
including duration of response, progression-free survival, and
overall survival. The clinical trial is being conducted under a
clinical trial collaboration agreement with Regeneron and full
commercial rights retained by Replimune. Libtayo is a registered
trademark of Regeneron.
About IGNYTE IGNYTE is
Replimune’s multi-cohort Phase 1/2 clinical trial of RP1 in
combination with Opdivo® (nivolumab). There are 3 tumor specific
cohorts in this clinical trial including a cohort in anti-PD1
failed melanoma with registrational intent that has completed
enrollment with 140 patients enrolled. This cohort was initiated
after completing enrollment in a prior Phase 2 cohort in the same
clinical trial of approximately 30 patients with melanoma. The
additional cohorts currently enrolling and are in non-melanoma skin
cancers which includes both naïve and anti-PD1 failed CSCC, and in
anti-PD1 failed microsatellite instability high, or MSI-H/dMMR
tumors. This trial is being conducted under a collaboration and
supply agreement with Bristol-Myers Squibb. Opdivo is a registered
trademark of Bristol-Myers Squibb.
About RP1 RP1 is Replimune’s lead
product candidate and is based on a proprietary new strain of
herpes simplex virus engineered and genetically armed with a
fusogenic protein (GALV-GP R-) and GM-CSF intended to maximize
tumor killing potency, the immunogenicity of tumor cell death, and
the activation of a systemic anti-tumor immune response.
About RP2 & RP3 RP2 and RP3
are derivatives of RP1 that express additional immune-activating
proteins. RP2 expresses an anti-CTLA-4 antibody-like molecule and
RP3 additionally expresses the immune co-stimulatory pathway
activating proteins CD40L and 4-1BBL, but does not express GM-CSF.
RP2 and RP3 are intended to provide targeted and potent delivery of
these proteins to the sites of immune response initiation in the
tumor and draining lymph nodes, with the goal of focusing systemic
immune-based efficacy on tumors and limiting off-target
toxicity.
About Replimune Replimune Group,
Inc., headquartered in Woburn, MA, was founded in 2015 with the
mission to transform cancer treatment by pioneering the development
of a novel portfolio of oncolytic immunotherapies. Replimune’s
proprietary RPx platform is based on a potent HSV-1 backbone
intended to maximize immunogenic cell death and the induction of a
systemic anti-tumor immune response. The RPx platform is designed
to have a unique dual local and systemic mechanism of action (MOA)
consisting of direct selective virus-mediated killing of the tumor
resulting in the release of tumor derived antigens and altering of
the tumor microenvironment to ignite a strong and durable systemic
response. This MOA is expected to be synergistic with most
established and experimental cancer treatment modalities, leading
to the versatility to be developed alone or combined with a variety
of other treatment options. For more information, please visit
www.replimune.com.
Forward Looking Statements This
press release contains forward looking statements within the
meaning of Section 27A of the Securities Act of 1933, as amended,
and Section 21E of the Securities Exchange Act of 1934, as amended,
including statements regarding our expectations about our cash
runway, the design and advancement of our clinical trials, the
timing and sufficiency of our clinical trial outcomes to support
potential approval of any of our product candidates, our goals to
develop and commercialize our product candidates, patient
enrollments in our existing and planned clinical trials and the
timing thereof, and other statements identified by words such as
“could,” “expects,” “intends,” “may,” “plans,” “potential,”
“should,” “will,” “would,” or similar expressions and the negatives
of those terms. Forward-looking statements are not promises or
guarantees of future performance, and are subject to a variety of
risks and uncertainties, many of which are beyond our control, and
which could cause actual results to differ materially from those
contemplated in such forward-looking statements. These factors
include risks related to our limited operating history, our ability
to generate positive clinical trial results for our product
candidates, the costs and timing of operating our in-house
manufacturing facility, the timing and scope of regulatory
approvals, the availability of combination therapies needed to
conduct our clinical trials, changes in laws and regulations to
which we are subject, competitive pressures, our ability to
identify additional product candidates, political and global macro
factors including the impact of the coronavirus as a global
pandemic and related public health issues and the Russian-Ukrainian
and Israel-Hamas political and military conflicts, and other risks
as may be detailed from time to time in our Annual Reports on Form
10-K and Quarterly Reports on Form 10-Q and other reports we file
with the Securities and Exchange Commission. Our actual results
could differ materially from the results described in or implied by
such forward-looking statements. Forward-looking statements speak
only as of the date hereof, and, except as required by law, we
undertake no obligation to update or revise these forward-looking
statements.
Investor Inquiries Chris Brinzey
ICR Westwicke 339.970.2843 chris.brinzey@westwicke.com
Media Inquiries Arleen Goldenberg
Replimune 917.548.1582 media@replimune.com
Replimune Group, Inc.
Condensed Consolidated Statements of Operations
(Amounts in thousands, except share and per share
amounts) (Unaudited)
|
|
Three Months Ended September 30, |
|
Six Months Ended September 30, |
|
|
|
2023 |
|
|
|
2022 |
|
|
|
2023 |
|
|
|
2022 |
|
|
|
|
|
|
|
|
|
|
Operating
expenses: |
|
|
|
|
|
|
|
|
Research and development |
|
$ |
49,101 |
|
|
$ |
28,834 |
|
|
$ |
89,538 |
|
|
$ |
58,312 |
|
Selling, general and
administrative |
|
|
14,730 |
|
|
|
12,745 |
|
|
|
29,941 |
|
|
|
24,143 |
|
Total
operating expenses |
|
|
63,831 |
|
|
|
41,579 |
|
|
|
119,479 |
|
|
|
82,455 |
|
Loss from
operations |
|
|
(63,831 |
) |
|
|
(41,579 |
) |
|
|
(119,479 |
) |
|
|
(82,455 |
) |
Other income
(expense): |
|
|
|
|
|
|
|
|
Research and development
incentives |
|
|
443 |
|
|
|
574 |
|
|
|
836 |
|
|
|
1,425 |
|
Investment income |
|
|
6,049 |
|
|
|
1,112 |
|
|
|
12,235 |
|
|
|
1,455 |
|
Interest expense on finance lease
liability |
|
|
(542 |
) |
|
|
(550 |
) |
|
|
(1,086 |
) |
|
|
(1,102 |
) |
Interest expense on debt
obligations |
|
|
(955 |
) |
|
|
- |
|
|
|
(2,070 |
) |
|
|
- |
|
Other (expense) income |
|
|
(1,409 |
) |
|
|
(2,659 |
) |
|
|
(35 |
) |
|
|
(4,678 |
) |
Total
other income (expense), net |
|
|
3,586 |
|
|
|
(1,523 |
) |
|
|
9,880 |
|
|
|
(2,900 |
) |
Loss before
income taxes |
|
$ |
(60,245 |
) |
|
$ |
(43,102 |
) |
|
$ |
(109,599 |
) |
|
$ |
(85,355 |
) |
Income tax (benefit) |
|
|
(201 |
) |
|
|
- |
|
|
|
- |
|
|
|
- |
|
Net
loss |
|
$ |
(60,044 |
) |
|
$ |
(43,102 |
) |
|
$ |
(109,599 |
) |
|
$ |
(85,355 |
) |
Net loss per
common share, basic and diluted |
|
$ |
(0.90 |
) |
|
$ |
(0.79 |
) |
|
$ |
(1.65 |
) |
|
$ |
(1.57 |
) |
Weighted
average common shares outstanding, basic and diluted |
|
|
66,582,280 |
|
|
|
54,770,291 |
|
|
|
66,475,577 |
|
|
|
54,492,395 |
|
|
|
|
|
|
|
|
|
|
Replimune Group, Inc.
Condensed Consolidated Balance Sheets
(Amounts In thousands, except share and per share
amounts) (Unaudited)
|
|
September
30, |
|
March
31, |
|
|
|
2023 |
|
|
|
2023 |
|
|
|
|
|
|
Consolidated Balance Sheet Data: |
|
|
|
|
Cash, cash
equivalents and short-term investments |
|
$ |
496,761 |
|
|
$ |
583,386 |
|
Working
capital |
|
|
468,343 |
|
|
|
558,778 |
|
Total
assets |
|
|
562,398 |
|
|
|
646,591 |
|
Total
stockholders' equity |
|
|
465,172 |
|
|
|
555,292 |
|
|
|
|
|
|
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